Events

Recall of Respironics BiPAP Focus Noninvasive Ventilator System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics California Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52016
  • Event Risk Class
    Class 1
  • Event Number
    Z-1606-2009
  • Event Initiated Date
    2008-09-22
  • Event Date Posted
    2009-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81912
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, non-life-supporting - Product Code MNS
  • Reason
    Power supply failures have occurred on some ventilators. a discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. a disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cau.
  • Action
    Respironics California, Inc. issued an "Attention - Medical Device Field Correction" letter addressed to the Customer/Distributor dated September 22, 2008. The letter informed consignees of the affected device and instructions for removal, device replacement and return of the Business Response form by fax to 1-760-918-0169. Further question may be addressed to Respironics US Customer Service at 1-9800-345-6443 extension 5 or Respironics International Customer Service at 1-724-387-4000.

Device

Respironics BiPAP Focus Noninvasive Ventilator System
  • Model / Serial
    Model Numbers: 8-400169-00, 7-400076-00, 8-400179-00, 8-400258-00, 8-400259-00, 8-400260-00, 8-400261-00 and 8-400216-00.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide to Argentina, Australia, Belgium, Brazil, Cambodia, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Portugal, Puerto Rico, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States and Venezuela.
  • Product Description
    Respironics BiPAP Focus Noninvasive Ventilator System. || The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, respiratory failure or to maintain airway patency and provide respiratory support to patients who experience obstructive sleep apnea. Nasal and full face masks are used with this device. The BiPAP Focus is intended for use in acute, sub-acute and intra-hospital transport settings.
  • Manufacturer
    Respironics California Inc

Manufacturer

Respironics California Inc
  • Manufacturer Address
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92011-1517
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA